SURE-POINT? TRACKER D0136200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-02 for SURE-POINT? TRACKER D0136200 manufactured by Bard Brachytherapy, Inc. -1424526.

MAUDE Entry Details

Report Number1018233-2019-06166
MDR Report Key9146390
Date Received2019-10-02
Date of Report2019-10-02
Date Mfgr Received2019-09-12
Date Added to Maude2019-10-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactYONIC ANDERSON
Manufacturer Street8195 INDUSTRIAL BLVD
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal30014
Manufacturer Phone7707846100
Manufacturer G1BARD BRACHYTHERAPY, INC. -1424526
Manufacturer Street295 EAST LIES ROAD
Manufacturer CityCAROL STREAM IL 60188
Manufacturer CountryUS
Manufacturer Postal Code60188
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSURE-POINT? TRACKER
Generic NameTRACKER CONTROL BOX
Product CodeITX
Date Received2019-10-02
Returned To Mfg2019-08-19
Model NumberD0136200
Catalog NumberD0136200
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerBARD BRACHYTHERAPY, INC. -1424526
Manufacturer Address295 EAST LIES ROAD CAROL STREAM IL 60188 US 60188


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-10-02

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